Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Apparently well conducted study
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Dilauroyl peroxide
EC Number:
203-326-3
EC Name:
Dilauroyl peroxide
Cas Number:
105-74-8
Molecular formula:
C24H46O4
IUPAC Name:
dodecanoyl dodecaneperoxoate
Constituent 2
Reference substance name:
Laurox
IUPAC Name:
Laurox
Details on test material:
A consignment of 100 g (net) Laurox, white flakes, was received from the Sponsor on 2 October 1992. The test material was further identified by the
Batch No. 0029209020111, the CAS No. 105-74-8 and the EINECS No. 2033263. It was stated Dilauroyl peroxide and was 99.7% pure.
It was stored in a refrigerator (approximately 4°C), in the original container. The identity, strength and purity of the test material received, and its
stability under the storage conditions above, were the responsibility of the Sponsor. A certificate of analysis for the batch of test material used
on this study is presented in Appendix 1.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Young albino rabbits of an outbred New Zealand White strain were supplied by Rosemead Rabbits, Rosemead, Waltham Abbey, Essex, England. They
were individually housed in suspended stainless steel cages mounted in mobile batteries (Modular Systems and Development Company limited,
London, England). The cages were fitted with perforated counter-sunk floor panels. A tray beneath the floor was lined with absorbent paper which was
changed regularly. Animals had free access to a commercially available standard pelleted rabbit diet (S.Q.C. Rabbit Diet, Special Diets Services
Limited, Witham, Essex, England). The rabbits had free access to tap water taken from the public supply; in England the supply and quality of this water is
governed by Department of the Environment regulations. Results of these analyses are retained in the archives. There was no information indicating
that normal levels of common contaminants, or specific contaminants, in the diet or drinking water would influence the outcome of the study.

The animals were housed in a lagomorph room within a limited-access building. The room was kept at slight positive pressure relative to the outside and had its own filtered air supply giving approximately 15 complete air changes per hour without re-circulation. A temperature range of 18-22°C
and a relative humidity range of 45-56% R.H. Electric time-switches operated a lighting cycle of 12 hours of artificial light per day. An emergency
generator was available to maintain the electricity supply in the event of a power failure.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated eye served as a control
Amount / concentration applied:
0.1 gram
Duration of treatment / exposure:
One instillation
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
Each rabbit was inspected on arrival and unsuitable individuals were rejected. Individual bodyweight was recorded for each animal on the day of
receipt and at weekly intervals thereafter. All animals were identified by a uniquely numbered ear-tag. During the acclimatization period, the health
status of each animal was monitored and a record kept. This record was consulted before an animal was allocated to study. Both eyes of each animal were examined before administration of the test material for signs of pre-existing irritation, reaction or abnormality which would prevent it from
being used on the study. Each cage was labelled with details of the schedule number, ear-tag number, sex, administration, treatment level,

Bodyweights on the day of dosing were within the range 3.04 - 4.52 kg. The rabbits were approximately either three or six months old at this time.

Each animal was gently restrained. The dose was instilled into the right eye by pulling the lower eye lid away from the eyeball to form a cup into
which 0.1 g of the test material was dropped. The eyelids were gently held together for one second and then released. The left eye remained
untreated.

The behaviour of each rabbit was observed for several minutes immediately following instillation of the test material to allow assessment of the initial pain response.

The animals were returned to their cages and checked at least twice during the first hour after dosing, at regular intervals throughout the day and
daily to ensure that the treated eye was not subject to infection or causing distress. Ocular reactions to treatment were assessed 1, 24, 48 and 72
hours after treatment. Reactions not included below were described in detail. Additional observations of persistent ocular lesions or irritation
responses were made seven days after treatment. The untreated eye was used as a comparison with the treated eye during assessment of ocular
lesions. An ophthalmoscope was used to facilitate inspection of the eyes.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks on result:
other: see table
Irritation parameter:
iris score
Remarks on result:
other: see table
Irritation parameter:
conjunctivae score
Remarks on result:
other: see table
Irritation parameter:
chemosis score
Remarks on result:
other: see table
Irritant / corrosive response data:
A diffuse crimson~red conjunctival appearance or injection of the conjunctival blood vessels was observed in all rabbits during the first 24 hours
following instillation, continuing in one animal to the 48 hour examination and in another up to the 72 hour examination. Very slight chemosis and
very slight or slight discharge were observed during the first 24 hours after treatment. The test eyes of two rabbits were overtly normal at the 72
hour examination; that of the remaining rabbit had recovered by the seventh day. Instillation of the test material caused practically no initial pain
response.
Other effects:
None

Any other information on results incl. tables

Summary of Ocular Lesions

Anim.

No.

Effect

Hours

Hours after application

Days after application

Mean

score cornea

24, 48, 72 hrs

Mean score iritis

24, 48, 72 hrs

Mean score redness 24, 48, 72 hrs.

Mean score chemosis 24, 48, 72 hrs.

1

24

48

72

4

7

1

Cornea

Iris

Redness

Chemosis

Discharge

Pain*

0

0

1

0

1

1

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0.3

0

2

Cornea

Iris

Redness

Chemosis

Discharge

Pain*

0

0

1

1

1

0

0

0

1

0

1

0

0

1

0

0

0

0

0

0

0

0

0

0.7

0

3

Cornea

Iris

Redness

Chemosis

Discharge

Pain*

0

0

2

1

2

1

0

0

2

0

0

0

0

1

0

0

0

0

1

1

0

0

0

0

0

0

0

0

1.3

0

*Evaluated upon instillation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A diffuse crimson~red conjunctival appearance or injection of the conjunctival blood vessels was observed in all rabbits during the first 24 hours
following instillation, continuing in one animal to the 48 hour examination and in another up to the 72 hour examination. Very slight chemosis and
very slight or slight discharge were observed during the first 24 hours after treatment. The test eyes of two rabbits were overtly normal at the 72
hour examination; that of the remaining rabbit had recovered by the seventh day. Instillation of the test material caused practically no initial pain
response. According to GHS, Laurox is not classified as an eye irritant.
Executive summary:

Laurox was evaluated for potential eye irritation following the instillation of 0.1 gram into rabbit eyes In accordance with OECD 405. Response to pain was evaluated upon instillation. Ocular reactions were evaluated 1, 24, 48 and 72 hours and 7 days following instillation.

A diffuse crimson~red conjunctival appearance or injection of the conjunctival blood vessels was observed in all rabbits during the first 24 hours following instillation, continuing in one animal to the 48 hour examination and in another up to the 72 hour examination. Very slight chemosis and very slight or slight discharge were observed during the first 24 hours after treatment. The test eyes of two rabbits were overtly normal at the 72 hour examination; that of the remaining rabbit had recovered by the seventh day. Instillation of the test material caused practically no initial pain response.

According to GHS, Laurox is not classified as an eye irritant.